Acting on black box warnings requires a GRADE evidence table and an implementation guide: The case of teriparatide

Tarig Elraiyah, Michael R. Gionfriddo, Mohammad H Murad

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Objectives To assess how well do the black box warnings present and communicate evidence in a way that is consistent with evidence-based patient-centered practice, through evaluating the boxed warning on teriparatide-induced osteosarcoma. Study Design and Setting We critically appraised teriparatide black box warning for osteosarcoma by reviewing human and animal studies that were used as basis for the warning. We also evaluated the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. Results We found that this warning was based on very low-quality evidence that was derived primarily from animal studies. The quality of evidence was rated down because of high risk of bias in addition to inconsistency, indirectness, and imprecision of the estimates. The warning does not provide sufficient guidance for practice like an implementation tool or an evidence profile to clarify the limitations of the evidence. Conclusion Black box warning for teriparatide-associated osteosarcoma does not explicitly present the quality of evidence, and therefore, it could be of limited use in evidence-based practice. We propose that black box warnings should include an evidence profile and an implementation guide to be more useful in evidence-based patient-centered practice.

Original languageEnglish (US)
Pages (from-to)698-702
Number of pages5
JournalJournal of Clinical Epidemiology
Volume68
Issue number6
DOIs
StatePublished - Jun 1 2015

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Drug Labeling
Teriparatide
Osteosarcoma
Evidence-Based Practice

Keywords

  • Black box warning
  • Evidence-based practice
  • GRADE
  • Implementation
  • Osteosarcoma
  • Quality of evidence
  • Teriparatide

ASJC Scopus subject areas

  • Epidemiology

Cite this

Acting on black box warnings requires a GRADE evidence table and an implementation guide : The case of teriparatide. / Elraiyah, Tarig; Gionfriddo, Michael R.; Murad, Mohammad H.

In: Journal of Clinical Epidemiology, Vol. 68, No. 6, 01.06.2015, p. 698-702.

Research output: Contribution to journalArticle

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